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HDCT and Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma

Primary Purpose

Low Grade Lymphoma

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
stem cell source
Sponsored by
Alberta Health services
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Grade Lymphoma focused on measuring autologous and allogeneic stem cell transplantation, low grade lymphoma, mantle cell

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: indolent histology lymphomas after relapse 1 or 2 LVEF > 50% Creatinine < 150 umol/L bilirubin < 30 umol/L wbc >3.5X10^9/L platelets >100X10^9/L other medical condition as controlled Exclusion Criteria: pregnant lactating HIV positive CNS involvement by lymphoma other malignancy

Sites / Locations

  • Tom Baker Cancer Centre

Outcomes

Primary Outcome Measures

feasibility
mortality
overall survival
event free survival

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
November 18, 2011
Sponsor
Alberta Health services
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1. Study Identification

Unique Protocol Identification Number
NCT00144092
Brief Title
HDCT and Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma
Official Title
High Dose Chemotherapy and Autologous or Allogeneic Blood Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Alberta Health services

4. Oversight

5. Study Description

Brief Summary
Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation.
Detailed Description
Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation if they have an HLA matched sibling, or an autologous transplant if they do not.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Grade Lymphoma
Keywords
autologous and allogeneic stem cell transplantation, low grade lymphoma, mantle cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
stem cell source
Primary Outcome Measure Information:
Title
feasibility
Title
mortality
Title
overall survival
Title
event free survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: indolent histology lymphomas after relapse 1 or 2 LVEF > 50% Creatinine < 150 umol/L bilirubin < 30 umol/L wbc >3.5X10^9/L platelets >100X10^9/L other medical condition as controlled Exclusion Criteria: pregnant lactating HIV positive CNS involvement by lymphoma other malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doug Stewart
Organizational Affiliation
Alberta Cancer Board - TBCC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21831743
Citation
Stewart DA, Duan Q, Carlson L, Russell JA, Bahlis NJ, Duggan P, Hasegawa W, Voralia M. A prospective phase II study of RICE re-induction, then high-dose fludarabine and busulfan, followed by autologous or allogeneic blood stem cell transplantation for indolent b-cell lymphoma. Clin Lymphoma Myeloma Leuk. 2011 Dec;11(6):475-82. doi: 10.1016/j.clml.2011.06.012. Epub 2011 Aug 10.
Results Reference
derived

Learn more about this trial

HDCT and Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma

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